UPC CD Munich, 16 July 2024: Lack of inventive step medical use product claim
25-07-2024 Print this page
Patent revoked because of lack of inventive step (Article 56 EPC). Starting from Lagace the skilled person having the aim to provide a treatment or way of prevention of […] would as a next step have pursued the route of developing antibodies that block the interaction between PCSK9 and LDLR as explicitly suggested by Lagace [….] [and] would have ended up with antibodies as defined in the claims without inventive skill..
Claim interpretation of a medical use product claim (Article 69 EPC). The relevant point in time for interpreting a patent claim for the assessment of validity is the filing (or priority) date of the application that led to the patent in suit. Medical use format claims (Article 54(4)(5) EPC) are purpose-limited product claims. The product specified in a medical use claim must be objectively suitable for the claimed use; it must be able to be used for the treatment, prevention or reduction as specified in the claim. In this sense, it must be therapeutically effective.
Skilled person is a team set out to solve a problem. The skilled person in this case is a team including someone having a university degree in biological sciences (or biochemistry) and several years of (post-doctorate) experience in the field of antibody technology and a researcher with a number of years post-doctorate research experience who is undertaking preclinical research into the treatment of cardiovascular diseases, and who has an interest in PCSK9 biology with respect to the role and function of PCSK9 in regulating LDL levels. The skilled person who, as rightly pointed out by the Defendant, is not an academic wishing to explore and understand the PCSK9 mechanism, but is a team that is set out to solve a problem, will consider a prior art document in its entirety in light of their common general knowledge and make realistic and practical deductions from a prior art teaching. The skilled person is aiming to solve a problem and in doing so is considering which next step(s), if any, are realistically to be taken. Absent any apparent errors or omissions in a prior art document, a skilled person will not be overly cautious (nor creative) and does not analyse every experiment in a prior art document in isolation with a view to the questions it does not answer but will rather be inclined to accept published (and peer reviewed) research results and reasonable conclusions drawn from those results at face value.
Interpretation of the claims (Article 69 EPC). The meaning of the term “catalytic domain” is not explicitly defined in the Patent. The catalytic domain is understood by the skilled person as the region consisting of amino acid residues 123 to 419 of human PCSK9 (SEQ ID NO: 1). Based on wording of the claim and the description. It follows from the above that Figure 26 does not contain the “sole definition” of the catalytic domain. Feature F.3 should not be considered in isolation; its meaning must be determined in light of the claim as a whole and the underlying problem.
Priority: “same invention” requirement (Article 87 EPC). A claimed invention is to be considered the same invention as the invention in a previous application if the skilled person can derive the subject-matter of the claim directly and unambiguously, using common general knowledge, from the previous application as a whole (cf. EPO Enlarged Board of Appeal 31 May 2001, G2/98, ECLI:EP:BA:2001:G000298.20010531).
Claimed subject matter is obvious and does not involve an inventive step (Article 56 EPC). An objective approach must be taken to the assessment of inventive step. Any starting point that has the same underlying problem as the claimed invention is a realistic starting point. In general, a claimed solution is obvious if, starting from the prior art, the skilled person would be motivated (i.e. have an incentive or in German: “Veranlassung”, see the CoA in NanoString/10x Genomics, p. 34) to consider the claimed solution and to implement it as a next step (“nächster Schritt”, CoA in NanoString/10x Genomics, p. 35, second par.) in developing the prior art. On the other hand, it may be relevant whether the skilled person would have expected any particular difficulties in taking any next step(s). Depending on the facts and circumstances of the case, it may be allowed to combine prior art disclosures. A technical effect or advantage achieved by the claimed subject matter compared to the prior art may be an indication for inventive step. A feature that is selected in an arbitrary way out of several possibilities cannot generally contribute to inventive step. Starting from Lagace the skilled person having the aim to provide a treatment or way of prevention of […] would as a next step have pursued the route of developing antibodies that block the interaction between PCSK9 and LDLR as explicitly suggested by Lagace [….] [and] would have ended up with antibodies as defined in the claims without inventive skill.
Left undecided whether a reasonable expectation of success is required. The absence of a reasonable expectation of success (or more in general: nonobviousness) does not follow from the mere fact that other ways of solving the underlying problem are also suggested in the prior art and/or (would) have been pursued by others. Requiring considerable time and resources does not constitute an “undue burden” in patent law terms. The skilled person would have realised that making antibodies and setting up the screening methods may require considerable time and resources, but to do so does not constitute an “undue burden” in patent law terms. That the inventors took a non-routine approach to obtain the functional antibodies does not mean that the skilled person would not arrive at such an antibody using routine methods..
Application to amend (auxiliary requests): Rule 30 RoP applies mutatis mutandis in a revocation action based on Rule 50 RoP.
